Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: MightySat RX Pulse Oximeter Sensor

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Competent non-smoking adults

Inclusion Criteria:

• Subjects must understand and consent to be in the study.
• American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

• Subjects who have any systemic disease at all.
• Subjects who do not understand the study and the risks.
• Smokers.
• Subjects who are pregnant.
• Subjects having either signs or history of peripheral ischemia.
• Others deemed ineligible by the clinical staff.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Subject; All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.	Device: MightySat RX Pulse Oximeter Sensor; Noninvasive pulse oximeter finger sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Sensor	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.	1-5 hours
Accuracy of Sensor during motion	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value.	1-5 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2014
• Primary Completion (Actual): December 17, 2014
• Study Completion (Actual): December 17, 2014

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TR27761-TP16850A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No